Clinical Study Documentation Specialist - Tieto Tech Consulting (m/f/d)
Core
Prepare and manage clinical study documentation, including Ethics Committee (EC) screenshot packages and Informed Consent Forms (ICFs), ensuring accuracy and portal configuration.
Role type
Clinical Study Documentation Specialist
Builds
Clinical study documentation packages and configured study portal materials
Domain
Clinical trials / Pharmaceutical
Required skills
Attention to detail, proficiency with documentation and digital portals, process adherence, organizational skills
Preferred skills
Experience in pharmaceutical or clinical trial domain, familiarity with ICFs and EC submissions
Responsibilities
Prepare and consolidate screenshot packages for Ethics Committee approval, Generate screenshots using dedicated tools, Prepare ICF documents in PDF format and configure them in a case study portal, Review study documentation and materials for completeness and accuracy, Manage user access including invitations and removal, Work with portals and internal tools following defined processes
Seniority
Individual Contributor